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Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking.

Nicotine patches are commonly used by people who try to quit smoking. Because high doses of nicotine may increase heart rate and potentiate cardiac arrhythmia or ischemia, its use in patients with coronary artery disease was investigated. The objective was to assess the cardiovascular safety of nicotine patches in patients with coronary artery disease (CAD) who try to quit smoking. The study was conducted in a double-blind, placebo-controlled, randomized fashion over a 2-week period. One hundred and six patients with CAD who wished to stop smoking and were taking part in a smoking cessation program were included. Fifty-two patients received nicotine patches (Nicotinell) and 54 received placebo patches. The cardiovascular effects of nicotine patches were assessed by repeated ambulatory ECG monitoring (AEM) and exercise testing. There were no changes in the resting heart rate and in the systolic or diastolic blood pressure between the screening and the two phases of the study in both the Nicotinell and placebo groups. Repeated 48-hour AEM revealed that there were no significant changes in the number and duration of ischemic episodes in both groups. There was no change in the frequency of atrial or ventricular arrhythmias. Exercise duration and time to 1-mm ST-segment depression increased in both groups during the double-blind treatment phase. More patients in the Nicotinell group claimed tobacco abstinence compared with the placebo group (27% vs. 13%). The use of nicotine patches did not cause aggravation of myocardial ischemia or arrhythmia in coronary patients and therefore can be used as a method to promote smoking cessation in this high-risk group.

Administration, Cutaneous↗

Behavior therapy and the transdermal nicotine patch: effects on cessation outcome, affect, and coping.

The process and outcome of a smoking cessation program using behavior therapy alone (BT) or behavior therapy plus the nicotine patch (BTP) was studied in 64 participants. Participants quit smoking on a target date after a period of ad libitum smoking, cognitive-behavior therapy preparing them for cessation, and behavioral rehearsal for high-risk situations, including stress management, and coping with negative affect. Abstinence was significantly higher for the BTP group versus the BT group from the end of behavioral treatment (79% vs. 63%) through the 3-month follow-up (p < .01), with the effects weakening at the 6- (p = .06) and 12-month marks (p = 38% vs. 22%). More general distress was observed among BT versus BTP participants (i.e., increased withdrawal, tension, fatigue, and coping frequency with decreased coping effort; coping-to-urge ratio). The coping behavior of the BTP group may have been more effective than that of the BT group, as indicated by their significantly higher level of self-efficacy.

Adaptation, Psychological↗

Development of matrix patches for transdermal delivery of a highly lipophilic antiestrogen.

The aim of this study was to develop matrix-type transdermal systems (TDSs) containing the highly lipophilic (log P = 5.82) antiestrogen (AE) and the permeation enhancers propylene glycol and lauric acid. For that purpose, permeation of AE from various adhesive matrices through excised skin of hairless mice was evaluated. It was found that pretreatment of the skin with permeation enhancers raised the transdermal flux of subsequently applied antiestrogen. Highest steady-state transdermal fluxes (1.1 microg cm(-2) h(-1)) were obtained from Gelva, polyacrylate adhesive, followed by 0.55 microg cm(-2) h(-1) from Oppanol polyisobutylene, 0.31 microg cm(-2) h(-1) from BIO-PSA silicone, and 0.12 microg cm(-2) h(-1) from Sekisui polyacrylate matrices. In order to develop TDS with high content of fluid permeation enhancer propylene glycol, two different strategies were investigated. One strategy was the addition of hydroxypropyl cellulose (HPC) as thickening agent to Gelva matrices. This allowed for propylene glycol loading levels of up to 30%, resulting in transdermal AE fluxes of 0.09 microg cm(-2) h(-1). On the other hand, a fleece-laminated backing foil was loaded with the described permeation enhancer formulation and laminated with polyacrylate adhesive layer, resulting in transdermal AE fluxes of 0.06 microg cm(-2) h(-1). However, application of these TDSs on skin pretreated with permeation enhancers raised the fluxes to 2.6 microg cm(-2) h(-1) from Gelva/HPC and 0.46 microg cm(-2) h(-1) from fleece/Sekisui.

Adhesives↗